HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes
Public ClinicalTrials.gov record NCT07546929. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Blood sugar levels are controlled by insulin, a hormone made by cells in the pancreas. After a meal, carbohydrates are broken down into glucose which is absorbed from the intestine into the blood leading to a rise in glucose (blood sugar) which triggers the secretion of insulin. Insulin binds to cells in several tissues including liver, muscle, and fat, triggering cells to take up glucose and bring the blood glucose level back to normal. A high blood sugar level is known as diabetes. The most common form of diabetes, type 2 diabetes, is caused by insulin resistance; that is, a reduced ability of insulin to stimulate glucose uptake into cells. The body compensates for insulin resistance by making more insulin; type 2 diabetes occurs when the pancreas can no longer make enough insulin to control blood glucose. The high blood glucose and insulin levels lead to long-term complications such as heart attacks, kidney failure, reduced sensation and poor circulation in the feet and legs. High insulin levels also increase the incidence of cancers, stroke, and dementia. Reducing blood glucose levels with oral medications and insulin reduces risk of diabetic complications. There are several types of oral medications available for treating diabetes; however, they do not always control blood glucose adequately. In addition, these drugs have complications and are not used to treat insulin resistance and prediabetes - a condition when blood glucose is higher than normal but not high enough to be classified as diabetes. Prediabetes often progresses to diabetes over a period of months or years. Effective and safe treatments for insulin resistance may prevent the onset of diabetes or even reverse diabetes if diagnosed in its early stages before substantial damage to the pancreas has occurred. HP-211 is a botanical extract whose active ingredients are derived from herbs and vegetables present in normal diets. HP-211 has been shown in laboratory studies in cell culture, in animal studies, and in a previous Phase 1 study to enhance the ability of insulin to stimulate glucose uptake into cells. Thus, HP-211 may reduce the blood glucose and circulating insulin levels of subjects with type 2 diabetes after a meal. HP-211 may also reduce glucose and insulin responses to a greater extent in insulin-resistant as compared to insulin-sensitive subjects. Subjects will take 0, 1, 2 or 3 tablets of HP-211 in the morning and evening for 90 days. Hemoglobin A1c (HbA1c, or "A1c"), a measure of the average amount of glucose present in the blood, will be measured during the trial period.
Study identification
- NCT ID
- NCT07546929
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2, 2023
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
- Last update posted
- Apr 22, 2026
2023 – 2026
United States locations
- U.S. sites
- 25
- U.S. states
- 12
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance Clinical Canoga Park (Hope Clinical Research) | Canoga Park | California | 91303 | Recruiting |
| Universal Axon Clinical Research | Doral | Florida | 33166 | Recruiting |
| Velocity Clinical Research New Smyrna Beach | Edgewater | Florida | 32132 | Recruiting |
| Southwest General Healthcare Center | Fort Myers | Florida | 33907 | Recruiting |
| Avantis Clinical Research | Miami | Florida | 33155 | Recruiting |
| IMIC Research | Miami | Florida | 33176 | Recruiting |
| South Broward Research | Miramar | Florida | 33027 | Recruiting |
| David Kavtaradze MD InC | Cordele | Georgia | 31015 | Recruiting |
| AMR Clinical - El Dorado | El Dorado | Kansas | 67042 | Recruiting |
| Tandem Clinical Research (Interspond) | Marrero | Louisiana | 70072 | Recruiting |
| Arcturus Healthcare, PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | Recruiting |
| Velocity Clinical Research Norfolk | Norfolk | Nebraska | 68701 | Recruiting |
| Alliance Clinical Las Vegas (Excel Clinical Research) | Las Vegas | Nevada | 89109 | Recruiting |
| Diabetes & Endocrinology Associates of Stark County, Inc. | Canton | Ohio | 44718 | Recruiting |
| Advanced Medical Research | Maumee | Ohio | 43537 | Recruiting |
| Velocity Clinical Research Providence | East Greenwich | Rhode Island | 02818 | Recruiting |
| Velocity Clinical Research Dallas | Dallas | Texas | 75230 | Recruiting |
| Tekton Research | Irving | Texas | 75039 | Recruiting |
| Alliance Clinical Lewisville (Epic Clinical Research) | Lewisville | Texas | 75057 | Recruiting |
| Tekton Research | McKinney | Texas | 75069 | Recruiting |
| Tekton Research | San Antonio | Texas | 78258 | Recruiting |
| Simcare Medical Research, LLC. | Sugar Land | Texas | 77478 | Recruiting |
| Velocity Clinical Research Waco | Waco | Texas | 76710 | Recruiting |
| Burke Internal Medicine & Research | Burke | Virginia | 22015 | Recruiting |
| Tekton Research | Midlothian | Virginia | 23112 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07546929, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 22, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07546929 live on ClinicalTrials.gov.